MAUDE Adverse Event Report: RESPIRONICS, INC. SYSTEM ONE HTD HUMID ASSY; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	DS6HFLG
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Headache (1880); Hypersensitivity/Allergic reaction (1907); Unspecified Respiratory Problem (4464); Unspecified Hepatic or Biliary Problem (4493); Unspecified Kidney or Urinary Problem (4503)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was contacted in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information that the patient alleging nose irritation, dizziness and/or headache, hypersensitivity, kidney disease/toxicity and liver disease/toxicity.There was no report of medical intervention.The device was returned to the manufacturer's product investigation laboratory for investigation.The manufacturer-initiated therapy with the device and verified airflow, using a known good manufacturer supplied power supply and ac power cord.Pil also observed customers humidifier heater plate did heat.The manufacturer observed the following sound abatement degraded foam indications: black substance, consistent with sound abatement foam degradation, was observed on the outside bottom of the blower box and was stuck to it.Black pieces of a black substance, consistent with sound abatement foam degradation, were found on the bottom of the enclosure.The manufacturer was able to confirm the presence of degraded sound abatement foam.Secondary findings: dust-like contamination at the air inlet, on the pca, in the blower box and throughout the inside enclosure.Dust-like contamination inside humidifier enclosure, on and under the heater plate, on the dry box and inside the water tank.Air inlet filter missing.Ui (user interface) knob broken.Extra pads added to bottom of base device and humidifier.The manufacturer can confirm the presence of multiple contaminants that are not consistent with degraded sound abatement foam from the secondary findings.The manufacturer was unable to address the symptoms specified.The manufacturer used a fitt (foam integrity test tool) and was able to confirm the presence of degraded sound abatement foam.The device's downloaded logs were reviewed by the manufacturer.There were no errors found.The manufacturer concludes there was evidence of sound abatement foam degradation in the device and was able to confirm the customer's complaint.
Additional Manufacturer Narrative
This report was submitted for the system one htd humid assy.The base device associated with this humidifier is reported under mdr 2518422-2024-35328.At this time of investigation, it has been determined that all reporting activities will be carried out in mdr 2518422-2024-35328.

• Brand Name: SYSTEM ONE HTD HUMID ASSY
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 23367128
• Report Number: 2518422-2025-049954
• Device Sequence Number: 8879934
• Product Code: BZD
• UDI-Device Identifier: 00606959032149
• UDI-Public: (01)00606959032149
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DS6HFLG
• Device Catalogue Number: DS6HFLG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/26/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1974-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown